MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,CERAMIC INSULATION.; INNER CERAMIC TUBE

Model Number	27040XB
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned product 27040xb and has not responded to our attempts to gather or confirm further information.The customer stated "plastic tip" however, our instrument has a ceramic beak, therefore, there is potential this could be a 3rd party repaired item.
Event or Problem Description
Per medwatch #mw5086564 we received, "plastic tip broke off during surgery, retrieved by surgeon".

• Brand Name: TUBE,INNER,CERAMIC INSULATION.
• Common Device Name: INNER CERAMIC TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8660684
• Report Number: 9610617-2019-00050
• Device Sequence Number: 2182879
• Product Code: FBO
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K943668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040XB
• Device Lot Number: PS03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other